Safety, tolerability & pharmacokinetics of regorafenib in paediatrics

• Research type

  Research Study

• Full title

  A multi-centre, open-label, non-randomised, phase I dose escalation study of regorafenib (BAY 73-4506) in paediatric subjects with solid malignant tumours that are recurrent or refractory to standard therapy.

• IRAS ID

  141557

• Contact name

  Andrew Pearson

• Contact email

  Andrew.Pearson@icr.ac.uk

• Sponsor organisation

  Bayer Healthcare AG delegated to Bayer Plc

• Eudract number

  2013-003579-36

• Duration of Study in the UK

  3 years, 9 months, 14 days

• Research summary

  This study includes two phases, dose escalation phase and dose expansion phase.
  Please note this amendment reflects the dose expansion phase, so I will describe only this expansion phase.

  The aim of this study is to investigate regorafenib (study drug) when taken with the two standard of care drugs, vincristine and irinotecan, in children and adolescents:
  -To determine which is the right regorafenib dose to be used in children and adolescents in combination with chemotherapy
  -To investigate the pharmacokinetics (explores what happens to the drug in the body) of regorafenib (study drug) in combination with chemotherapy
  -To investigate the pharmacokinetics (explores what happens to the drug in the body) of irinotecan when given with regorafenib
  -To assess the acceptability of any side effects of regorafenib in children and adolescents
  -To assess if the addition of regorafenib to the vincristine and irinotecan chemotherapy increases the tumor response
  -To assess the acceptability of the taste and texture of the study drug tablets and granules by children

• REC name

  London - City & East Research Ethics Committee

• REC reference

  14/LO/0122

• Date of REC Opinion

  11 Mar 2014

• REC opinion

  Further Information Favourable Opinion